PROJECT SUMMARY?ABSTRACT The Biostatistics & Bioinformatics Core is responsible for all statistical, bioinformatics, and data management activities for each of the SPORE projects, the developmental and career development research projects, and the Cores. The Core deliberately leverages and builds upon strong existing institutional infrastructure by providing investigators access to statistical and bioinformatics expertise and extensive Mayo Clinic Cancer Center (MCCC) and Division of Biomedical Statistics and Informatics (BSI) infrastructure. Each of the projects presented in this application reflects input from members of the Biostatistics & Bioinformatics Core with respect to the design and analysis plan. The research studies will be conducted across different platforms with different data management needs, from in vivo murine models to a phase I and II clinical trial to correlative studies of biospecimens from clinical trials and an existing tumor registry. The Core will provide statistical expertise including experimental design for laboratory studies, statistical modeling, analysis of high-dimensional data, design and analyses of correlative studies using biospecimens, and sound clinical trial design. The Core will also provide bioinformatics support for processing, analysis, and interpretation of genomics data, as well as for long-term storage and planning future analysis needs. Members of the Biostatistics & Bioinformatics Core in consultation with the biostatistics and bioinformatics faculty in the Division of BSI, will explore, implement and develop appropriate designs and analyses to address the aims of the individual projects. The Core will oversee the data management and integration of existing and newly collected data through consistent and compatible data handling. In addition, members of this Core will complement and assist the efforts of other Cores such as the Biospecimens & Clinical Database Core with superior data management, and experience with institutional databases. The strengths of the Biostatistics & Bioinformatics Core are our collaborative relationship with each of the projects and Cores, the operational, statistical, and bioinformatics infrastructures already in place in the MCCC and the Division of BSI, and the diverse and extensive statistical and bioinformatics experience of the Core members. Overall, the Biostatistics & Bioinformatics Core builds upon the innovative and time-tested procedures and systems developed by one of the largest statistical and bioinformatics groups in the country, which has supported more than 13,000 clinical, translational, and basic science research studies since 1966.